Phase 1 Hepatitis B Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are generally well enough to carry out light activity and care for themselves, with little or no restriction on daily activities (measured by a standard medical scale called ECOG, with a score of 0 or 1)
• People who have been diagnosed with liver cancer (hepatocellular carcinoma) that can be measured on scans, and where standard treatments have either not worked or are not suitable
• People who test positive for a hepatitis B surface protein in their blood (called HBsAg), indicating a hepatitis B infection
• People whose liver is either not scarred (non-cirrhotic) or has mild, well-managed scarring (compensated cirrhosis), based on a liver health scoring system called Child-Pugh A (5–6 points)
• People who are expected to live for at least 3 months
• People whose immune system tissue type (called HLA class 1 profile) matches one of two specific markers used in this trial (HLA-A*02:01 or HLA-A*24:02) — the trial site can check this through testing

Who may not be able to join:

• People whose cancer has spread to the brain
• People who have a second active cancer at the time of enrolment, with some exceptions — certain early-stage or low-risk cancers such as cervical carcinoma in situ, non-melanoma skin cancer, localised prostate cancer, ductal carcinoma in situ, Stage I uterine cancer, or superficial bladder tumours may still be considered (confirm with trial site)
• People who have recently used certain cancer-fighting drugs known as immune checkpoint inhibitors or tyrosine kinase inhibitors (TKIs), within a specific timeframe before the initial liver biopsy (confirm exact timeframe with trial site)
• People who have had changes to their regular medications within 3 months before the initial liver biopsy, where those medication changes could potentially cause liver damage or affect biopsy results
• People who are likely to need immune-suppressing medications at any point during the trial
• People who have had a liver procedure called RFA or TACE within 3 months before the first treatment infusion, or a procedure called Y90 therapy within 6 months before the first treatment dose
• People whose liver scarring is advanced and poorly managed (decompensated cirrhosis, Child-Pugh B or C, scoring 7–15 points)
• People currently receiving any other cancer treatment, including chemotherapy, hormonal therapy, or immunotherapy
• People who have taken part in another clinical trial or used an experimental treatment or device within 30 days before this trial's treatment begins
• People with hepatitis B virus DNA levels of 200 IU/ml or higher in their blood at the screening stage
• People with hepatitis B surface antigen (HBsAg) levels of 10,000 IU/ml or higher in their blood at the screening stage
• People for whom it is not possible to access a suitable vein for treatment or blood sample collection, or who have any condition that would interfere with receiving the treatment or providing study samples
• People who have an active infection or any other condition that, in the treating doctor's opinion, makes participation unsuitable
• People who are pregnant or breastfeeding

Important: Always verify eligibility with the trial site directly before applying.